Tags

Type your tag names separated by a space and hit enter

Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial.
Diabetes Care. 2016 Nov; 39(11):2026-2035.DC

Abstract

OBJECTIVE

To evaluate efficacy and safety of LixiLan (iGlarLixi), a novel titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi), compared with both components, iGlar and Lixi, given separately in type 2 diabetes inadequately controlled on metformin with or without a second oral glucose-lowering drug.

RESEARCH DESIGN AND METHODS

After a 4-week run-in to optimize metformin and stop other oral antidiabetic drugs, participants (N = 1,170, mean diabetes duration ∼8.8 years, BMI ∼31.7 kg/m2) were randomly assigned to open-label once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum insulin dose of 60 units/day, or to once-daily Lixi (20 μg/day) while continuing with metformin. The primary outcome was HbA1c change at 30 weeks.

RESULTS

Greater reductions in HbA1c from baseline (8.1% [65 mmol/mol]) were achieved with iGlarLixi compared with iGlar and Lixi (-1.6%, -1.3%, -0.9%, respectively), reaching mean final HbA1c levels of 6.5% (48 mmol/mol) for iGlarLixi versus 6.8% (51 mmol/mol) and 7.3% (56 mmol/mol) for iGlar and Lixi, respectively (both P < 0.0001). More subjects reached target HbA1c <7% with iGlarLixi (74%) versus iGlar (59%) or Lixi (33%) (P < 0.0001 for all). Mean body weight decreased with iGlarLixi (-0.3 kg) and Lixi (-2.3 kg) and increased with iGlar (+1.1 kg, difference 1.4 kg, P < 0.0001). Documented symptomatic hypoglycemia (≤70 mg/dL) was similar with iGlarLixi and iGlar (1.4 and 1.2 events/patient-year) and lower with Lixi (0.3 events/patient-year). iGlarLixi improved postprandial glycemic control versus iGlar and demonstrated considerably fewer nausea (9.6%) and vomiting (3.2%) events than Lixi (24% and 6.4%, respectively).

CONCLUSIONS

iGlarLixi complemented iGlar and Lixi effects to achieve meaningful HbA1c reductions, close to near normoglycemia without increases in either hypoglycemia or weight, compared with iGlar, and had low gastrointestinal adverse effects compared with Lixi.

Authors+Show Affiliations

Dallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.Grunberger Diabetes Institute, Bloomfield Hills, MI.GWT-TUD GmbH, Dresden Technical University, Dresden, Germany.San Raffaele Scientific Institute, Milan, Italy.Groupe Hospitalier Mutualiste Les Portes du Sud, Vénissieux, France.Sanofi R&D, Beijing, China.Sanofi, Bridgewater, NJ.Diabetes Division, Sanofi, Frankfurt, Germany.Diabetes Division, Sanofi, Paris, France.Diabetes Research Centre, University of Leicester, Leicester, U.K.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27527848

Citation

Rosenstock, Julio, et al. "Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled On Oral Agents: the LixiLan-O Randomized Trial." Diabetes Care, vol. 39, no. 11, 2016, pp. 2026-2035.
Rosenstock J, Aronson R, Grunberger G, et al. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care. 2016;39(11):2026-2035.
Rosenstock, J., Aronson, R., Grunberger, G., Hanefeld, M., Piatti, P., Serusclat, P., Cheng, X., Zhou, T., Niemoeller, E., Souhami, E., & Davies, M. (2016). Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care, 39(11), 2026-2035.
Rosenstock J, et al. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled On Oral Agents: the LixiLan-O Randomized Trial. Diabetes Care. 2016;39(11):2026-2035. PubMed PMID: 27527848.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. AU - Rosenstock,Julio, AU - Aronson,Ronnie, AU - Grunberger,George, AU - Hanefeld,Markolf, AU - Piatti,PierMarco, AU - Serusclat,Pierre, AU - Cheng,Xi, AU - Zhou,Tianyue, AU - Niemoeller,Elisabeth, AU - Souhami,Elisabeth, AU - Davies,Melanie, AU - ,, Y1 - 2016/08/15/ PY - 2016/04/27/received PY - 2016/07/18/accepted PY - 2016/8/17/pubmed PY - 2017/10/6/medline PY - 2016/8/17/entrez SP - 2026 EP - 2035 JF - Diabetes care JO - Diabetes Care VL - 39 IS - 11 N2 - OBJECTIVE: To evaluate efficacy and safety of LixiLan (iGlarLixi), a novel titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi), compared with both components, iGlar and Lixi, given separately in type 2 diabetes inadequately controlled on metformin with or without a second oral glucose-lowering drug. RESEARCH DESIGN AND METHODS: After a 4-week run-in to optimize metformin and stop other oral antidiabetic drugs, participants (N = 1,170, mean diabetes duration ∼8.8 years, BMI ∼31.7 kg/m2) were randomly assigned to open-label once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum insulin dose of 60 units/day, or to once-daily Lixi (20 μg/day) while continuing with metformin. The primary outcome was HbA1c change at 30 weeks. RESULTS: Greater reductions in HbA1c from baseline (8.1% [65 mmol/mol]) were achieved with iGlarLixi compared with iGlar and Lixi (-1.6%, -1.3%, -0.9%, respectively), reaching mean final HbA1c levels of 6.5% (48 mmol/mol) for iGlarLixi versus 6.8% (51 mmol/mol) and 7.3% (56 mmol/mol) for iGlar and Lixi, respectively (both P < 0.0001). More subjects reached target HbA1c <7% with iGlarLixi (74%) versus iGlar (59%) or Lixi (33%) (P < 0.0001 for all). Mean body weight decreased with iGlarLixi (-0.3 kg) and Lixi (-2.3 kg) and increased with iGlar (+1.1 kg, difference 1.4 kg, P < 0.0001). Documented symptomatic hypoglycemia (≤70 mg/dL) was similar with iGlarLixi and iGlar (1.4 and 1.2 events/patient-year) and lower with Lixi (0.3 events/patient-year). iGlarLixi improved postprandial glycemic control versus iGlar and demonstrated considerably fewer nausea (9.6%) and vomiting (3.2%) events than Lixi (24% and 6.4%, respectively). CONCLUSIONS: iGlarLixi complemented iGlar and Lixi effects to achieve meaningful HbA1c reductions, close to near normoglycemia without increases in either hypoglycemia or weight, compared with iGlar, and had low gastrointestinal adverse effects compared with Lixi. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/27527848/Benefits_of_LixiLan_a_Titratable_Fixed_Ratio_Combination_of_Insulin_Glargine_Plus_Lixisenatide_Versus_Insulin_Glargine_and_Lixisenatide_Monocomponents_in_Type_2_Diabetes_Inadequately_Controlled_on_Oral_Agents:_The_LixiLan_O_Randomized_Trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=27527848 DB - PRIME DP - Unbound Medicine ER -